The present disclosure relates generally to a reconstitution assembly. More specifically, the present disclosure relates to a drug reconstitution assembly for reconstituting a lyophilized drug.
Certain drugs are supplied in lyophilized form. The lyophilized drug must be mixed with water to reconstitute the drug into a form suitable for injection into a patient. In particular, all of the components that contact the drugs must be sterile to avoid the chance of infection.
The reconstitution process presents difficulties for many people which are in need of injecting themselves or another family member in a home environment. The general process requires the exact, sequential manipulation of the drug vial, the diluent container and the transfer syringes which must utilize needles to penetrate the vial stoppers. This process should be done with good aseptic practices.
In addition, many lyophilized drugs are provided in vials having the interior at a negative pressure relative to the atmosphere. This negative pressure facilitates reconstitution as it compensates for the volume of diluents which is injected into the vial for reconstitution. If air is allowed to enter into the interior of the vial prior to the injection of the diluents, this may make the reconstitution process much more difficult for the patient or health care provider.
Thus, reconstitution presents challenges in ensuring sterility of the product and providing ease of use to the patient or caregiver. The lyophilized drugs are often very expensive, making the minimization of the mechanical and user error of the utmost importance to avoid product waste. In particular, it is desirable to maintain user interaction with the reconstitution assembly to a minimum and to minimize the number of steps in the reconstitution process. In addition it is desirable to prevent unintentional or intentional tampering with the diluent or drug container and reuse of the reconstitution assembly. Moreover, it is desirable to minimize or eliminate the ability of the user to negatively impact the reconstitution process during user interaction.